MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for PILLCAM MB9-GCD-K manufactured by Medtronic Inc..
[107359746]
Patient Sequence No: 1, Text Type: N, H10
[107359747]
During an endoscopic pillcam deployment in the duodenum using an us endoscopy deployment device, deployment of pillcam failed. As the scope was removed, some blood was noted. Upon closer inspection of the pillcam and deployment device once the scope was removed, it was noted that the pillcam was still sitting the deployment device and the deployment rod had slipped thru the pillcam holder.
Patient Sequence No: 1, Text Type: D, B5
[108947578]
Patient Sequence No: 1, Text Type: N, H10
[108947579]
During an endoscopic pillcam deployment in the duodenum using an us endoscopy deployment device, deployment of pillcam failed. As the scope was removed, some blood was noted. Upon closer inspection of the pillcam and deployment device once the scope was removed, it was noted that the pillcam was still sitting. The deployment device and the deployment rod had slipped thru the pillcam holder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7486613 |
| MDR Report Key | 7486613 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-02-08 |
| Report Date | 2018-04-10 |
| Date Reported to FDA | 2018-04-10 |
| Date Reported to Mfgr | 2018-04-10 |
| Date Added to Maude | 2018-05-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | CAPSULE |
| Product Code | NEZ |
| Date Received | 2018-05-04 |
| Model Number | MB9-GCD-K |
| Catalog Number | MB9-GCD-K |
| Lot Number | 38918X |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 710 MEDTRONIC PKWY MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | PILLCAM |
| Generic Name | CAPSULE |
| Product Code | PGD |
| Date Received | 2018-05-04 |
| Model Number | MB9-GCD-K |
| Catalog Number | MB9-GCD-K |
| Lot Number | 38918X |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 710 MEDTRONIC PKWY MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |